RecruitingNot ApplicableNCT04231838

Metabolic Syndrome in Diabetic Smokers Using Cigarettes & Combustion-Free Nicotine Delivery Systems

A Randomised Controlled International Multicentre Study Evaluating Changes in Metabolic Syndrome in Smokers With Type 2 Diabetes Mellitus After Switching From Tobacco Cigarettes to Combustion-Free Nicotine Delivery Systems: DIASMOKE Study

Sponsor

Eclat Srl.

Enrollment

576 participants

Start Date

Sep 27, 2021

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 2 Cardiovascular Risk Factor

Summary

Very little is known about the impact of combustion-free nicotine delivery systems (C-F NDS) on cardiovascular risk factors in T2DM patients who smoke. Data from clinical studies to identify any potential reduction in individuals' risk, relative to the risk of continued smoking, are needed. This study aims to test the hypothesis that avoiding exposure to cigarette smoke toxicants may translate to measurable improvement in cardiovascular risk factors and functional parameters when T2DM patients who smoke switch to using C-F NDS compared with T2DM patients who continue to smoke conventional tobacco products. The investigators propose a prospective 2-year multicenter randomized controlled trial (RCT) to evaluate changes in cardiovascular risk factors and functional parameters in diabetic smokers using C-F NDS and compared to those continuing cigarette smoking.

Eligibility

Min Age: 23 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether switching from regular cigarettes to heated tobacco products or e-cigarettes affects metabolic health (like blood sugar and weight) in people with type 2 diabetes who smoke. Researchers want to understand the health impacts of different nicotine products in diabetics. **You may be eligible if...** - You are 23 or older - You have type 2 diabetes (with HbA1c between 6.0 and 12) - You currently smoke at least 10 and no more than 30 cigarettes per day - You have smoked for at least 5 consecutive years - Your cotinine (a nicotine marker) or exhaled carbon monoxide levels confirm you are a smoker - Your BMI is between 17.6 and 34.5 **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have had a recent acute illness or health event in the past 4 weeks - You are unwilling to follow the study product requirements for your assigned group - You are not a regular smoker Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERTOBACCO CIGARETTES

Participants in Arm A will continue smoking their own cigarette brand as usual.

OTHERCOMBUSTION-FREE NICOTINE DELIVERY SYSTEMS (C-F NDS)

Participants in Arm B will trial and familiarize with their allocated products to select the C-F NDS of their preference. They will be trained and counselled on the chosen C-F NDS; participants will also have the option to try and choose among a selection of either 3 e-liquids or 3 tobacco sticks (depending on the C-F NDS they have chosen). Participants wishing to use a heated tobacco device (HTD) will receive one kit and a full 1 week supply of tobacco sticks of their choice (they will receive a number of tobacco sticks/day corresponding to the number of cigarettes smoked at baseline); those wishing to use a vaping product will receive one vaping kit and a full 1 week supply of e-liquids of their choice (they will receive 4 x 10 ml refill containers).